Active Trials

Working with researchers at Baylor Scott & White Health and institutions around the globe, our physicians, surgeons and advanced practice providers oversee a wide selection of clinical trials.

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Study Name: PREVENT

Study Title: A randomized, double-blind, placebo-controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease
Sponsor: Novartis
PI: East
Therapeutic Group: Heart Failure

Study Name: ADVANCE LAA

Study Title: A Real-World Study to Observe Outcomes of Patients Undergoing Closure with the Amplatzer Amulet Left Atrial Appendage Occluder
Sponsor: Abbott Medical Devices
PI: Mughal
Therapeutic Group: Cardiology

Study Name: Engulf

Study Title: A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device For the Treatment of Pulmonary Embolism (ENGULF)
Sponsor: Endovascular Engineering
PI: Dib
Therapeutic Group: Heart Failure

Study Name: ACT II

Study Title: A Study to Evaluate the Safety and Effectiveness of Voyager’s Access Device for Patients Undergoing Routine Hemodialysis (Access Cannulation Trial II)
Sponsor: Voyager Biomedical
PI: Hohmann
Therapeutic Group: Vascular

Study Name: AAA-SHAPE

Study Title: AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Sponsor: Shape Memory Medical Inc.
PI: Kedora/Vasquez
Therapeutic Group: Heart Failure

Study Name: VT-PAS

Study Title: Abbott Ventricular Tachycardia Post Approval Study
Sponsor: Abbott Medical Devices
PI: Rao
Therapeutic Group: Cardiology

Study Name: TRILUMINATE

Study Title: ABT-CIP-10249: Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal (TRILUMINATE Pivotal)
Sponsor: Abbott Medical Devices
PI: Choi
Therapeutic Group: Heart Failure

Study Name: ACURATE IDE

Study Title: ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve through Implantation of ACURATE in Subjects InDicatEd for TAVR
Sponsor: Boston Scientific Corporation
PI: Stoler/Potluri
Therapeutic Group: Vascular

Study Name: ALL-RISE

Study Title: Advancing Cath Lab Results with FFRangio® Coronary Physiology Assessment: The ALL-RISE Study
Sponsor: CathWorks
PI: Al-Azizi
Therapeutic Group: Cardiology

Study Name: ALLIANCE

Study Title: ALLIANCE: Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve
Sponsor: Edwards Lifesciences
PI: Al-Azizi/Stoler
Therapeutic Group: Heart Failure

Study Name: CPET AlloSure

Study Title: AlloSure test characteristics in immunologically quiescent and immunologically active heart transplant recipients: does maximal cardiopulmonary stress testing prior to assay preserve test specificity while enhancing sensitivity?
Sponsor: Baylor Scott & White Research Institute
PI: Gottlieb
Therapeutic Group: Aortic Valve

Study Name: PFO Occluder/Stroke

Study Title: Amplatzer PFO Occluder Post Approval Study
Sponsor: Abbott Medical Devices
PI: Potluri
Therapeutic Group: Cardiology

Study Name: eVO2

Study Title: An Observational, Non-Interventional Study Supporting Validation of VO2Max estimation Methods using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
Sponsor: Prolaio, Inc. 
PI: Afzal
Therapeutic Group: Tricuspid

Study Name: Vutrisiran OLE

Study Title: An Open-Label Extension Study to Assess the Safety and Efficacy of Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy)
Sponsor: Alnylam
PI: Kale
Therapeutic Group: Electrophysiology

Study Name: CRT – Nitro

Study Title: Analysis Of Coronary Reactivity Testing With And Without Intracoronary Nitrate Testing
Sponsor: Abbott Medical Devices
PI: Widmer
Therapeutic Group: Vascular

Study Name: CTSN PACES

Study Title: Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
Sponsor: Abiomed
PI: DiMaio/Sayfo
Therapeutic Group: Mitral Valve

Study Name: AIM HIGHer

Study Title: Assessment of Implantable CCM in the Heart Failure Group with Higher Ejection Fraction
Sponsor: Impulse Dynamics
PI: Bindra/Mughal/Banchs
Therapeutic Group: Vascular

Study Name: Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

Study Title: Assessment of Long Term, Endovascular AAA Intervention using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
Sponsor: W.L.Gore & Associates
PI: Gable
Therapeutic Group: Vascular

Study Name: BIOFLOW VII

Study Title: BIOTRONIK – A Prospective Multicenter Study to Confirm the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions – VI
Sponsor: Biotronik, Inc.
PI: Stoler
Therapeutic Group: Vascular

Study Name: BACKBEAT Trial

Study Title: BradycArdia paCemaKer with AV interval modulation for Blood prEssure treAtmenT (BACKBEAT Trial)
Sponsor: Orchestra Biomed
PI: Assar
Therapeutic Group: Heart Failure

Study Name: CSWG

Study Title: Cardiogenic Shock Working Group Registry
Sponsor: Tufts Medical Center
PI: Gohar/Hernandez-Montfort/Hall/Afzal
Therapeutic Group: Cardiology

Study Name: CLASP TR EFS

Study Title: CLASP TR EFS: Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study
Sponsor: Edwards Lifesciences
PI: Smith Ii
Therapeutic Group: Vascular

Study Name: CLEAN-PE

Study Title: CLEAN-PE: A Prospective, Multicenter Study to Evaluate the Safety and Efficacy of an Aspiration Thrombectomy System in Acute Pulmonary Embolism
Sponsor: Argon Medical Devices
PI: Rosol/Dib
Therapeutic Group: Aortic Valve

Study Name: CATALYST

Study Title: Clinical trial of atrial fibrillation patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants
Sponsor: Abbott Medical Devices
PI: Mughal/Potluri
Therapeutic Group: Vascular

Study Name: Impella Rehab

Study Title: Comparing Outcomes of a Comprehensive Exercise Training Program Versus Usual Care in Patients with Axillary Impella as a Bridge to Transplant or Left Ventricular Assistive Device
Sponsor: Baylor Scott & White Research Institute
PI: Brown
Therapeutic Group: Heart Failure

Study Name: LYTEN

Study Title: Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable Evolut (R/PRO) System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprostheses: A Pilot Prospective Randomized Trial.
Sponsor: Laval University – Quebec
PI: Al-Azizi
Therapeutic Group: Heart Failure

Study Name: COSIRA-II

Study Title: COSIRA-II: Efficacy of the COronary SInus Reducer in Patients with Refractory Angina II
Sponsor: Neovasc Medical, Inc 
PI: Potluri
Therapeutic Group: Cardiology

Study Name: ObeseRightHeart

Study Title: Deciphering the Impact of Obesity on the Right Heart
Sponsor: CVRRC
PI: Sannino
Therapeutic Group: Aortic Valve

Study Name: DISCOVER-HCM

Study Title: Deliver Insights in Hypertrophic Cardiomyopathy and Observational outcomes in Real World (DISCOVER-HCM): United States Prospective Registry Study
Sponsor: Bristol Myers Squibb Company
PI: Gottlieb/Rawitscher/Nguyen
Therapeutic Group: Tricuspid

Study Name: Epiaortic

Study Title: Detection of Aortic Arch Re-Entry Tears Using Epiaortic Ultrasound during Surgical Management of Acute Type A Aortic Dissection
Sponsor: CVRRC
PI: Hafen
Therapeutic Group: Aortic Valve

Study Name: DRAIN-HF

Study Title: Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
Sponsor: Procyrion
PI: Guerrero Miranda/Sayfo
Therapeutic Group: Aortic Valve

Study Name: Doraya-HF

Study Title: Doraya-HF: Assessment of the Doraya Catheter for the treatment of volume overload in Acute Heart Failure Patients with Insufficient Response to Diuretics – Early Feasibility Study
Sponsor: Revamp
PI: Guerrero Miranda
Therapeutic Group: Aortic Valve

Study Name: Calyan Pacemaker EFS

Study Title: Early Feasibility Evaluation of a Novel Pacemaker System
Sponsor: Calyan Technologies
PI: Manhas
Therapeutic Group: Tricuspid

Study Name: CARMAT TAH

Study Title: Early Feasibility of the Carmat Total Artificial Heart
Sponsor: Carmat SA
PI: Meyer
Therapeutic Group: Vascular

Study Name: RESTOR-BTK

Study Title: Early Feasibility Study for Peripheral-5 CTO Crossing System (PER-5) in Below-The-Knee (BTK) Arteries
Sponsor: AngioSafe Inc  
PI: Eidt/Sayfo
Therapeutic Group: Vascular

Study Name: CardioMech EFS

Study Title: Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)  
Sponsor: CardioMech A.S.
PI: Al-Azizi/Smith Ii
Therapeutic Group: Cardiovascular Surgery

Study Name: Cardioband Tricuspid EFS

Study Title: Edwards Cardioband™ Tricuspid Valve Reconstruction System Early Feasibility Study
Sponsor: Edwards Lifesciences
PI: Smith Ii
Therapeutic Group: Cardiovascular Surgery

Study Name: CardiaAQ/EVOQUE MR/MISCEND

Study Title: Edwards EVOQUE Eos Mitral Valve Replacement: Investigation of Safety and Performance after Mitral Valve Replacement with Transcatheter Device (Rev O.1)
Sponsor: Edwards Lifesciences
PI: Szerlip/Smith Ii
Therapeutic Group: Vascular

Study Name: TRISCEND II Pivotal, CAS

Study Title: Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device – Edwards TRISCEND II Pivotal Trial
Sponsor: Edwards Lifesciences
PI: Szerlip/Smith Ii
Therapeutic Group: Cardiovascular Surgery

Study Name: EVOQUE TR EFS (TRISCEND)

Study Title: Edwards EVOQUE Tricuspid valve Replacement: Investigation of Safety and Clinical Efficacy after replacemeNt of tricuspid valve with transcatheter Device (TRISCEND Study)
Sponsor: Edwards Lifesciences
PI: Smith Ii
Therapeutic Group: Vascular

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